PANTOPRAZOLE SODIUM | N209463 | HIKMA PHARMACEUTICALS LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Lachman Consultant Services, Inc. FDA-2018-P-1099 · 6 docket documents Lachman Consultant Services, Inc. filed this petition requesting that the FDA designate Pantoprazole Sodium Powder for IV infusion 40 mg base per vial marketed by Excela Pharma Sciences LLC (NDA 209463, approved via the 505(b)(2) pathway) as an additional reference listed drug, allowing generic appl | 505(q) | 2018-03-13 | Withdrawn | Lachman Consultant Services, Inc. |
Citizen Petition from Hyman, Phelps, & McNamara, P.C. (Exela Pharma Sciences ) FDA-2017-P-4791 · 4 docket documents Hyman, Phelps & McNamara, P.C. filed this citizen petition on behalf of Exela Pharma Sciences requesting that the FDA assign a Therapeutic Equivalence Code of "AP" in the Orange Book for Exela's Pantoprazole Sodium for Injection, 40 mg/vial, which was approved under NDA 209463 on June 30, 2017 pursu | 505(q) | 2017-08-09 | Withdrawn | Hyman, Phelps, & McNamara, P.C. (Exela Pharma Sciences ) |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$2.37
per ea
Lowest NADAC/Unit
$2.37
per ea
Brand NDCs
0
Generic NDCs
2
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00143928410PANTOPRAZOLE SODIUM 40 MG VIAL | $2.37 | EA | Generic | — | 2026-03-18 |
| 00143930010PANTOPRAZOLE SODIUM 40 MG VIAL | $2.37 | EA | Generic | — | 2026-03-18 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.